Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant

• Published in: Journal of pain research Vol. 17; pp. 1209 - 1222
• Main Authors: Calodney, Aaron, Azeem, Nomen, Buchanan, Patrick, Skaribas, Ioannis, Antony, Ajay, Kim, Christopher, Girardi, George, Vu, Chau, Bovinet, Christopher, Vogel, Rainer, Li, Sean, Jassal, Navdeep, Josephson, Youssef, Lubenow, Timothy, Lam, Christopher M, Deer, Timothy R
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2024; Dove; Dove Medical Press
• Subjects: back pain; Backache; Cells; Clinical trials; Medical equipment and supplies industry; Medical test kit industry; minimally invasive spine surgery; Original Research; sacroiliac fusion; sacroiliac joint disease; sacroiliitis; single point posterior fusion; Transplantation of organs, tissues, etc; Florida; United States; sacroiliac fusion; single point posterior fusion; sacroiliitis; back pain; minimally invasive spine surgery; sacroiliac joint disease
• ISSN: 1178-7090; 1178-7090
• DOI: 10.2147/JPR.S458334

Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. Initially, devices designed for MIS were intended for lateral approaches. A minimally invasive sacroiliac fusion implant for use with a posterior approach has been developed and is regulated for clinical use under the regulatory framework required for human cells, tissues, or cellular or tissue-based products (HCT/Ps). A multi-center, prospective, single-arm study was launched after initial studies provided preliminary data to support safety, efficacy, and durability of this minimally invasive sacroiliac posterior fusion LinQ allograft implant (NCT04423120). Preliminary results were reported previously. Final results for the full participant cohort are presented here. One-hundred and fifty-nine (159) participants were enrolled across 16 investigational sites in the US between January 2020 and March 2022. One-hundred and twenty-two (122) participants were implanted. At the 1-month follow-up, 82 participants satisfied all criteria for the composite responder endpoint, representing 73.2% of the study cohort. These results stayed consistent across the remaining study timepoints with 66.0%, 74.4%, and 73.5% of participants classified as responders at the 3-, 6- and 12-month follow-up visits, respectively. VAS scores were significantly reduced (p < 0.0001) and ODI scores were significantly improved (p < 0.0001). All domains of the PROMIS-29 were also significantly improved (all p's <0.0001). Only one procedure-related serious AE was reported in the study. These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach.